Intersurgical recalls flexible breathing circuits with exhalation port 22mm due to risk of blocking during assembly, potentially causing serious patient health issues. Affected units include specific product numbers listed in the recall.
When assembling an HME or Filter on this breathing circuit the tubing may be pushed up and inadvertently cover or block the exhalation port. This could potentially pose a serious health risk to the patient.
Intersurgical is recalling flexible breathing circuits with exhalation ports that may block during assembly, which could cause serious health risks for patients. This recall affects specific product models sold in the U.S. and requires users to check their units against the listed serial numbers.
When assembling a breathing circuit with a heat exchange module (HME) or filter, the tubing may push up and cover the exhalation port. This blockage could prevent proper exhalation, leading to potential serious health risks for patients.
Healthcare professionals using these breathing circuits during patient care are most at risk. Patients using the circuits could face serious health issues if the exhalation port becomes blocked.
Check the product serial numbers listed: 0261604, 0671602, 0671603, 0741609, 0751601, 0821605, 0821606, 0891605, 0891606, 0951609, 0961601, 1751601, 0011802, 0011803, 0021803, 0081808, and 0161805.
Compare your unit's serial number with the list provided in the recall to confirm if it is affected.
The breathing circuit may block the exhalation port when assembling with a heat exchange module or filter, potentially causing serious health risks for patients.
Check the serial number against the list: 0261604, 0671602, 0671603, 0741609, 0751601, 0821605, 0821606, 0891605, 0891606, 0951609, 0961601, 1751601, 0011802, 0011803, 0021803, 0081808, and 0161805.
The recall does not specify a remedy, so contact Intersurgical directly for guidance on next steps.
We’ve drafted a message you can send Intersurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2302-2018 — Intersurgical Intersurgical Hello, I own a Intersurgical that is covered by recall Z-2302-2018 from Intersurgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
